Nasal Septum
Conditions
Keywords
Evaluation, ENTact™, Septal, Staple, System, tissue, approximation, during, septoplasties
Brief summary
The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.
Detailed description
The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate: * surgical performance of the ENTact Septal Staple System * one week post op clinical evaluation of gross tissue appearance at implantation site(s) * ENTact™ Septal Staple functionality based on maintained coaptation
Interventions
None listed
Sponsors
ENTrigue Surgical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum * Patient is able to provide a signed informed consent form * Patient will agree to comply with all study related procedures * Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery * Patient does not plan on becoming pregnant and is not breast feeding during the course of the study
Exclusion criteria
* Patients who do not meet the inclusion criteria * Patients who have had previous septoplasty * Patients with uncontrolled diabetes * Presence of infection at the site * Smokers and severe drug and alcohol abusers * Patients with autoimmune disease deemed clinically significant by Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coaptation (Tissue Approximation) | One week post surgery | Complete tissue approximation at one week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Reaction to Implant | One week post surgery | None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples. |
Countries
United States
Participant flow
Recruitment details
Chart reviews and patient contact in clinic. Recruitment period from July 2008 to January 2009.
Participants by arm
| Arm | Count |
|---|---|
| Septal Stapler Group Adult population (ages 18-65) with clinically significant nasal septum deviation. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Septal Stapler Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 39.9 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Outcome results
Primary
Coaptation (Tissue Approximation)
Complete tissue approximation at one week.
Time frame: One week post surgery
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Septal Stapler Group | Coaptation (Tissue Approximation) | 23 participants |
Secondary
Tissue Reaction to Implant
None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.
Time frame: One week post surgery
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Septal Stapler Group | Tissue Reaction to Implant | No reaction | 18 participants |
| Septal Stapler Group | Tissue Reaction to Implant | Mild reaction | 5 participants |
| Septal Stapler Group | Tissue Reaction to Implant | Moderate reaction | 0 participants |
| Septal Stapler Group | Tissue Reaction to Implant | Severe reaction | 0 participants |
| Septal Stapler Group | Tissue Reaction to Implant | Cannot assess | 2 participants |